Gliadel Wafer

Newly diagnosed high-grade malignant glioma — as an adjunct to surgery and radiation; Recurrent glioblastoma multiforme — as an adjunct to surgery in patients for whom surgical resection is indicated.

Up to 8 wafers placed in the resection cavity at the time of surgery
Each wafer contains 7.7 mg carmustine (total maximum: 61.6 mg)
Wafers should be placed to cover as much of the resection cavity as possible
Slight overlapping of wafers is acceptable
Oxidized regenerated cellulose may be placed over wafers
Storage: Store at or below -20°C. Unopened foil pouches may be kept at room temperature for maximum 6 hours.

Implant (wafer): 7.7 mg carmustine per wafer in a biodegradable polifeprosan 20 copolymer. Package of 8 wafers.

Hypersensitivity to carmustine or any component of the wafer.

• Seizures: New or worsening seizures in 37% of newly diagnosed patients (vs 29% placebo). Prophylactic anticonvulsants recommended. Median onset: 3-5 days post-surgery.
• Intracranial Hypertension: Brain edema resulting from the implant can mimic tumor progression. Brain edema with mass effect in 23%.
• Impaired Neurosurgical Wound Healing: CSF leaks (5%), subdural/subgaleal or wound effusions, wound dehiscence.
• Meningitis: Reported in 4% of new glioma patients.
• Wafer Migration: Wafer migration through craniotomy is possible; communication between resection cavity and ventricular system may increase risks.
• Myelosuppression: Systemic absorption may cause thrombocytopenia and leukopenia. Monitor CBC.

Seizures (37%), brain edema (23%), hemiplegia (19%), headache (15%), healing abnormalities (14%), nausea (12%), infection (5-9%), confusion (10%), CSF leak (5%), fever (18%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Gliadel wafers provide local, sustained release of carmustine (BCNU) directly into the tumor resection cavity. Carmustine is a nitrosourea alkylating agent that alkylates DNA at the O6-position of guanine, forming interstrand cross-links that inhibit DNA replication and transcription. The biodegradable polifeprosan 20 (poly[bis(p-carboxyphenoxy)propane:sebacic acid] 20:80) copolymer matrix slowly erodes over 2-3 weeks, delivering carmustine locally at high concentrations while minimizing systemic exposure.

Wafer dissolves over 2-3 weeks in the resection cavity. Carmustine concentrations in brain tissue surrounding the wafers are much higher than achievable by IV administration. Systemic exposure is minimal. The biodegradable polymer is eliminated by hydrolysis over approximately 6-8 weeks.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• Gliadel Phase III — Carmustine wafer vs. placebo wafer at initial surgery for malignant glioma. Phase III, n=240.
  🔬 NCT00003818 ↗ 📄 Primary Publication ↗

Gliadel Wafer has FDA-approved indications across the following cancer types covered on PipelineEvidence: